Published: 2 September 2021


Recent approvals: new active ingredients or new indications

Published: 2 September 2021
Prescriber Update 42(3): 36
September 2021

For the period 16 April 2021 to 15 July 2021.

Recent approvals of medicines with new active ingredients

Trade name (active ingredient) Dose form and strength(s) Therapeutic area
Beovu (brolizumab) Solution for injection
120 mg/mL vial
120 mg/mL pre-filled syringe
Neovascular age-related macular degeneration
COVID-19 Vaccine Janssen* (Ad26.COV2.s) Suspension for injection
5x1010 virus particles/0.5 mL
Immunisation to prevent COVID-19 in adults aged 18 years and older
* COVID-19 Vaccine Janssen has provisional approval.

Approved medicines with new indications

Trade Name (active ingredient) Dose form and strength(s) New therapeutic area(s)
Biktarvy (bictegravir; emtricitabine; tenofovir alafenamide) Film coated tablet
50 mg/200 mg/25 mg
HIV-1 infection in paediatric patients weighing at least 25 kg
Cabometyx (cabozantinib) Film coated tablet
20 mg
40 mg
60 mg
Hepatocellular carcinoma
Comirnaty (COVID-19 mRNA vaccine)* Concentrate for injection
0.5 mg/mL
Immunisation to prevent COVID-19 in adolescents aged 12 to 15 years old
Dysport (botulinum toxin type A) Powder for injection
300 U
500 U
Focal spasticity of upper limbs in children aged 2 years and older
Zavicefta (ceftazidime; avibactam) Powder for infusion
2000 mg/500 mg
Infections in paediatric (aged 3 months and older) patients

* Comirnaty has provisional approval.

See the Medsafe website for:

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